Efficacy and Safety of Auricular Acupuncture for Depression

This randomized clinical trial analyzes the safety and efficacy of auricular acupuncture as a treatment for depression.


ELIGIBILITY
The study's eligibility was assessed in a prescreening conducted in a dedicated room, ensuring participant integrity, confidentiality, and anonymity.The following inclusion and exclusion criteria were employed for the study.

INCLUSION CRITERIA
• Age between 18 and 50 years; • Attainment of minimum PHQ-9 scores for moderate/moderately severe depression; • Availability during the session timings.

EXCLUSION CRITERIA
• Use of complementary therapies for a minimum of 3 months; • Risk of suicidal ideation assessed through question 9 of the PHQ-9; • Severe depression assessed via PHQ-9 scores; • Prior application of auricular acupuncture; • Pregnancy; • Menopause; • Allergy to metals and micropores; • Healthcare students with a history of complementary therapies in the curriculum; • Individuals with scheduled vacations during the data collection period;   Used for liver-related issues, intercostal neuralgia, and ocular conditions.

Kidney / CO10 Shen
In the cymba conchae, in a groove below the start of the inferior crus.
Used for issues in the urinary and genital systems.Assists with tinnitus, auditory conditions, and sleep disorders.

External Ear / LO6 Neier
In the depression between the tragus's upper end and the helix's ascending spine.
Used for inflammatory changes in the external ear.It assists with tinnitus, hearing loss, and temporomandibular joint pain.Cheek/Face / LO5 -LO6 Mianjia In an oval portion in the region of the 2 nd , 3 rd , 5 th , and 6 th quadrants.
Used for myofascial spasms, facial paresis, and trigeminal neuralgia.
4 Non-specific points in the Helix region / HX9 Lunyi; HX10 Lunar; HX11 Lunsan; HX12 Lunsi On the margin of the auricle, between the helix tubercle and the apex, and between the tubercle and the lower lobe point.
Used for thirst control.

PRIMARY OUTCOME
The primary outcome was the difference in the proportion of participants who showed an improvement of 50% or more in depressive symptoms between the groups, as assessed by the PHQ-9 three months after inclusion.A followup score after 3 months showed a 50% improvement compared to baseline value was considered as a success or recovery of symptoms.

SECONDARY OUTCOMES
The secondary outcomes of the study were included to enrich the understanding of the primary outcome and to evaluate different aspects related to depressive symptoms and the auricular acupuncture intervention.
• Difference in the proportion of participants who showed an improvement of 50% or more in depressive symptoms between the groups, as assessed by the PHQ-9, at assessments conducted after four and six weeks of study inclusion.• Difference in the proportion of participants who achieved a score lower than 5 on the PHQ-9, indicating symptom remission between the groups, as assessed at assessments conducted after four, six weeks, and three months of study inclusion.• Differences in depression scores assessed by the PHQ-9 at baseline, the end of the fourth and sixth weeks of auricular acupuncture application, and also three months after inclusion between the groups.• Difference in the proportion of adverse events reported by participants through the PHQ-9 after four, six weeks, and three months of study inclusion.• Difference in the proportion of adverse effects of auricular acupuncture throughout the sessions between the groups.
• Evaluation of blinding and perceived efficacy between the groups.

a
Wilcoxon-Mann-Whitney Unpaired b Test Friedman's ANOVA followed by post-hoc test Legend: Q1: first quartile; Q3: third quartile eFigure 4. Median Depression Scores by Modified Intent-to-Treat Analysis

eTable 4. Loss to Follow-Up Throughout the Study
a Statistical significance was calculated with Fisher exact test.

eTable 13: Blinding Assessment and Perception of Treatment Efficacy
a Statistical significance was calculated with Fisher's exact test.